Cleared Special

K014225 - BREATHTEK - UBIT UBT FOR H. PYLORI

K014225 is an FDA 510(k) clearance for BREATHTEK - UBIT UBT FOR H. PYLORI, manufactured by Meretek Diagnostics, Inc.. The device is a Class 1 Microbiology device with product code MSQ cleared through the Special 510(k) pathway after a 22-day FDA review.

K014225 · Meretek Diagnostics, Inc. · Microbiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2002
Decision
22d
Days
Class 1
Risk

K014225 is an FDA 510(k) clearance for the BREATHTEK - UBIT UBT FOR H. PYLORI. Classified as Test, Urea (breath Or Blood) (product code MSQ), Class I - General Controls.

Submitted by Meretek Diagnostics, Inc. (Nashville, US). The FDA issued a Cleared decision on January 17, 2002 after a review of 22 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3110 - the FDA microbiology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K014225

510(k) Number K014225 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 26, 2001
Decision Date January 17, 2002
Days to Decision 22 days
Submission Type Special
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
80d faster than avg
Panel avg: 102d · This submission: 22d
Pathway characteristics
Modification to existing cleared device.

MSQ Device Classification - Class 1, General Controls

Product Code MSQ Test, Urea (breath Or Blood)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.3110
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - MSQ Test, Urea (breath Or Blood)

All 16
Devices cleared under the same product code (MSQ) and FDA review panel - the closest regulatory comparables to K014225.
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POCONE INFRARED SPECTROPHOTOMETER
K041148 · Otsuka Pharmaceutical Co., Ltd. · Jul 2004
VALIDATION OF THE BREATHID SYSTEM, FOR THE DETECTION OF HELICBACTOR PYLORI
K011668 · Oridion Medical 1987 , Ltd. · Jul 2001
MERETEK UBT_LITE BREATH TEST FOR H. PYLORI
K000316 · Meretek · Feb 2000
EZ-HBT HELICOBACTER BLOOD TEST
K990931 · Metabolic Solutions, Inc. · Sep 1999
K014225 · BREATHTEK - UBIT UBT FOR H. PYLORI
Download PDF FDA Summary Meretek Diagnostics, …